NDC codes

FDA NDC Directory
Product NDC (as listed)43538-940Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43538-0940Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
43538-940-60435380940601 TUBE in 1 CARTON (43538-940-60) / 60 g in 1 TUBEMarketed from Jun 11, 1963
43538-940-99435380940994 TUBE in 1 CARTON (43538-940-99) / 3 g in 1 TUBEMarketed from Jun 11, 1963

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Neo-Synalar
Generic name (nonproprietary)
neomycin sulfate and fluocinolone acetonide
Active ingredients
Neomycin sulfate — 3.5 mg/gFluocinolone acetonide — .25 mg/g
Dosage form
Cream
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 060700
Marketing start
Listing expires
Other FDA classes
Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 43538-940_b176bc29-53fc-48a1-bf09-ba250f1d13d7SPL ID b176bc29-53fc-48a1-bf09-ba250f1d13d7SPL set ID 1141956e-8a4c-4f80-95d1-f15bdb57fdf6RxCUI 1191359, 1542994UNII 057Y626693, 0CD5FD6S2M
Pharmacologic class
Aminoglycoside Antibacterial; Corticosteroid

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N443538094060 followed by a unit qualifier and the quantity

Package 43538-0940-60. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE NEO-SYNALAR ® cream is indicated for the treatment of corticosteroid-responsive dermatoses with secondary infection. It has not been demonstrated that this steroid-antibiotic combination provides greater benefit than the steroid component alone after 7 days of treatment (see WARNINGS section) .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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